Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Not Applicable

Completed

• Conditions: Periodontitis, Adult; Periodontitis; Periodontal Attachment Loss; Periodontal Pocket
• Interventions: Device: SRP and Fotosan 630

• Registration Number: NCT03453476
• Lead Sponsor: National University of Singapore

Brief Summary

Systemically healthy periodontitis patients were recruited in this single-blind, split-mouth, randomized controlled clinical trial. After SRP, PDT was applied at probing depth (PD) ≥ 4 mm at test quadrant. At baseline, 3rd month and 6th month, clinical parameters and cytokine pattern in gingival crevicular fluids (GCFs) were analysed.

Detailed Description

Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2013-03-31
• Study Completion: 2013-06-30
• Study First Submitted: 2018-01-23
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Study First Posted: 2018-03-05
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Adults who were medically fit or have medical condition that did not alter the outcome of periodontal treatment.
• Females who were not pregnant or nursing.
• Controlled diabetes mellitus with HbA1c < 7.5 mmol/L.
• Not on any antibiotics or steroids 3 months prior to periodontal treatment.
• Diagnosed to have either localized or generalized chronic or aggressive periodontitis (Armitage, 1999) with all 4 quadrants having at least 2 sites with probing depth ≥ 4 mm.
• Consented to follow the non-surgical periodontal treatment (scaling and root planing) with PDT throughout the period of study, i.e. approximately 6 months.

Exclusion Criteria

• Allergic to photosensitizer or dye
• Pregnant lady and nursing mothers
• Uncontrolled diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP and Fotosan 630	SRP and Fotosan 630	Scaling and root planing, photodynamic therapy using Fotosan 630

Primary Outcome Measures

Name	Time	Method
Changes from baseline clinical attachment level at 3rd month and 6th month	3 months and 6 months	Clinical attachment level in mm
Changes from baseline Interleukin-8 level at 3rd month and 6th month	3 months and 6 months	Interleukin-8 level in gingival crevicular fluid
Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month	3 months and 6 months	Matrix metalloproteinase-8 level in gingival crevicular fluid
Changes from baseline bleeding score at 3rd month and 6th month	3 months and 6 months	Bleeding score in percentage
Changes from baseline Interleukin-6 level at 3rd month and 6th month	3 months and 6 months	Interlekin-6 level in gingival crevicular fluid
Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month	3 months and 6 months	Tumour necrosis factor-alpha level in gingival crevicular fluid
Changes from baseline probing depth at 3rd month and 6th month	3 months and 6 months	Clinical probing depth in mm
Changes from baseline gingival recession level at 3rd month and 6th month	3 months and 6 months	Gingival recession level in mm
Changes from baseline Interleukin-1 level at 3rd month and 6th month	3 months and 6 months	Interleukin-1 level in gingival crevicular fluid